Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c…
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Read the official notice →- Date
- 2023-05-31
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and…
- Classification
- Class II
- Units
- US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ortho-Clinical Diagnostics recalls
- 2023-08-02
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FDA · DeviceOrtho-Clinical DiagnosticsWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-06-07
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Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data…
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Nationwide Foreign: Brazil, Chile, ColombiaOfficial notice → - 2023-05-10
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Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
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FDA · DeviceOrtho-Clinical Diagnostics, Inc.Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil…Official notice → - 2023-04-26
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Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data…
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
FDA · DeviceOrtho-Clinical Diagnostics, Inc.US Nationwide distribution in the states of AL, AZ, CA, GA, NY.Official notice → - 2023-01-11
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Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone…
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
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- 2023-06-07
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Denison Pharmaceuticals, LLC recalls Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated,…
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